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Unoprostone isopropyl - Generic Drug Details
What are the generic sources for unoprostone isopropyl and what is the scope of patent protection?
Unoprostone isopropyl
is the generic ingredient in one branded drug marketed by Sucampo Pharma Llc and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Unoprostone isopropyl has twenty-one patent family members in eighteen countries.
There are four drug master file entries for unoprostone isopropyl.
Summary for unoprostone isopropyl
| International Patents: | 21 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 4 |
| Bulk Api Vendors: | 17 |
| Clinical Trials: | 1 |
| Patent Applications: | 790 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for unoprostone isopropyl |
| DailyMed Link: | unoprostone isopropyl at DailyMed |
Recent Clinical Trials for unoprostone isopropyl
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sucampo Pharmaceuticals, Inc. | Phase 2 |
Recent Litigation for unoprostone isopropyl
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| SUCAMPO AG v. TEVA PHARMACEUTICAL INDUSTRIES LTD. | 2017-09-25 |
| Allergan, Inc. v. Sandoz, Inc. | 2015-10-19 |
Synonyms for unoprostone isopropyl
| 120373-24-2 |
| 373U242 |
| 5-Heptenoic acid, 7-((1R,2R,3R,5S)-3,5-dihydroxy-2-(3-oxodecyl)cyclopentyl)-, 1-methylethyl ester, (5Z)- |
| 5M161S5O5P |
| AKOS015965062 |
| C25H44O5 |
| CAS-120373-24-2 |
| CHEBI:31731 |
| CHEMBL1200661 |
| D01452 |
| DSSTox_CID_28997 |
| DSSTox_GSID_49071 |
| DSSTox_RID_83262 |
| DTXSID5049071 |
| Eescula |
| GTPL8282 |
| HMS3648F04 |
| isopropyl (5Z,9alpha,11alpha)-9,11-dihydroxy-15-oxo-20a,20b-dihomoprost-5-en-1-oate |
| isopropyl (Z)-7-((1R,2R,3R,5S)-3,5-dihydroxy-2-(3-oxodecyl)cyclopentyl)hept-5-enoate |
| isopropyl 20-ethyl-9alpha,11alpha-dihydroxy-15-keto-cis-delta-5-prostanoate |
| isopropyl unoprostone |
| Isopropyl unoprostone (JAN) |
| isopropyl(Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-{3-oxo-1-decyl}cyclopentyl]-hept-5-enoate |
| LS-176760 |
| LS-74384 |
| N919 |
| NCGC00183877-01 |
| Ocuseva |
| propan-2-yl (5Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-(3-oxodecyl)cyclopentyl]hept-5-enoate |
| propan-2-yl (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-(3-oxodecyl)cyclopentyl]hept-5-enoate |
| Q27089094 |
| Rescula |
| Rescula (proposed trade name) |
| SCHEMBL192726 |
| SR-01000946493 |
| SR-01000946493-1 |
| Tox21_113629 |
| UF 021 |
| UF 21 (urethane polymer) |
| UF-021 |
| UF-21 |
| UNII-5M161S5O5P |
| Unoprostone isopropyl ester |
| XXUPXHKCPIKWLR-JHUOEJJVSA-N |
| ZINC14234780 |
Paragraph IV (Patent) Challenges for UNOPROSTONE ISOPROPYL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| RESCULA | SOLUTION/DROPS;OPHTHALMIC | unoprostone isopropyl | 021214 | 2014-05-12 |
US Patents and Regulatory Information for unoprostone isopropyl
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for unoprostone isopropyl
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | Start Trial | Start Trial |
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | Start Trial | Start Trial |
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for unoprostone isopropyl
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | 0300391 | Start Trial |
| New Zealand | 521325 | Start Trial |
| Mexico | PA02008967 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for unoprostone isopropyl
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0289349 | C300135 | Netherlands | Start Trial | PRODUCT NAME: UNOPROSTONEZUUR, DESGEWENST IN DE VORM VAN EEN ESTER OF EEN ZOUT; NATL REGISTRATION NO/DATE: RVG 28628 20030708; FIRST REGISTRATION: FR 359 911-5 AND 359 912-1 20020917 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
